FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Medline UNITE® REFLEX® Nitinol Staple Kit
K Number: K232905
·
Decision Oct 19, 2023
Classifications
1
FEI Numbers
245
Registration Numbers
245
Same Product Code
230
Applicant Total
29
Review Days
30
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Basic Information
- Device Name
- Medline UNITE® REFLEX® Nitinol Staple Kit
- K Number
- K232905
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medline Industries, LP
- Date Received
- September 19, 2023
- Decision Date
- October 19, 2023
- Product Code
- JDR
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| JDR | Staple, Fixation, Bone | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JDR), ordered by most recent decision date.
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COGNiTiON Staple System
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